MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	H7493926024270
Medical Device Problem Codes	Bent (1059); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that removal difficulties and stent damage occurred.A 2.75 x 24mm synergy ii drug-eluting stent was advanced to treat the lesion.The device was removed to perform further dilatation.Upon removal, the device snagged on the guide catheter and the stent started to pull from the balloon and appeared to have folded over on itself.The guide catheter was pulled into the aorta and through wire manipulation, the device was removed.The procedure was completed with another stent of the same size.There were no patient complications.
Event or Problem Description
It was reported that removal difficulties and stent damage occurred.A 2.75 x 24mm synergy ii drug-eluting stent was advanced to treat the lesion.The device was removed to perform further dilatation.Upon removal, the device snagged on the guide catheter and the stent started to pull from the balloon and appeared to have folded over on itself.The guide catheter was pulled into the aorta and through wire manipulation, the device was removed.The procedure was completed with another stent of the same size.There were no patient complications.
Additional Manufacturer Narrative
Device avail.For eval, returned to mfr.On, device returned to mfr., device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr.: synergy ii us mr 2.75 x 24mm stent delivery system was returned for analysis.A visual examination of the crimped stent identified damage.The proximal end of the stent was bunched and pushed towards the mid-section of the stent.The distal section of the stent was undamaged.The undamaged distal crimped stent outer diameter was measured and was within maximum crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the device revealed multiple hypotube kinks.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage.The tip was visually and microscopically examined and no issues were noted.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7583640
• Report Number: 2134265-2018-05044
• Device Sequence Number: 11391596
• Product Code: NIQ
• UDI-Device Identifier: 08714729840220
• UDI-Public: 08714729840220
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/03/2018
• Device Model Number: H7493926024270
• Device Catalogue Number: 39260-2427
• Device Lot Number: 0020861254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1